International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis/vulvovaginitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 7
- 主要终点
- Proportion (%) of patients with clinical and microbiological response (recovery)
研究概览
简要总结
This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.
详细描述
The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking : Single (Evaluator-blinded)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 60 years.
- •Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
- •Negative pregnancy test at screening.
- •Agreement to use reliable contraception throughout the study and for 30 days after its completion.
- •Signed informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Diagnosed bacterial vaginosis.
- •Chronic inflammatory or atrophic diseases of the female genital organs.
- •History of malignant neoplasms.
- •Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.
研究组 & 干预措施
Clotrimazole+Lactulose
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
干预措施: Clotrimazole+Lactulose. (Drug)
Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
干预措施: Canesten (Clotrimazole) (Drug)
Lactulose
Vaginal suppositories containing lactulose (300 mg)
干预措施: Lactulose (Drug)
结局指标
主要结局
Proportion (%) of patients with clinical and microbiological response (recovery)
时间窗: Day 25 (Visit 4)
次要结局
- Proportion (%) of patients with clinical response (recovery)(by Visits 2 (Day 8) and 3 (Day 15))
- Proportion (%) of patients with microbiological recovery(by Visits 2 (Day 8) and 3 (Day 15))
- Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale(by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25))
- Patient evaluation of therapy efficacy using a 5-point scale(at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25))
- Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline(by Visits 3 (Day 15) and 4 (Day 25))